[Public Papers of the Presidents of the United States: William J. Clinton (1997, Book II)]
[November 21, 1997]
[Pages 1626-1627]
[From the U.S. Government Publishing Office www.gpo.gov]

Statement on Signing the Food and Drug Administration Modernization Act 
of 1997
November 21, 1997

    I am pleased to sign into law S. 830, the ``Food and Drug 
Administration Modernization Act of 1997.'' This bipartisan legislation 
culminates several years of work by my Administration and the Congress 
on steps to streamline and rationalize the process by which the Food and 
Drug Administration (FDA) approves new drugs and medical devices, while 
ensuring that these products, on which the American people rely, are 
safe and effective. The Act represents the most comprehensive reform of 
our Nation's drug, medical device, and food laws in decades. I believe 
that it is a good compromise on a difficult set of issues and am pleased 
that the Congress and my Administration were able to work through these 
issues and enact a bipartisan bill. Most importantly, I am pleased that 
S. 830 addresses my key concern that any FDA legislation maintain our 
high standards to protect the American people from dangerous drugs, 
devices, and foods.
    This legislation will extend through Fiscal Year 2002, the 
Prescription Drug User Fee Act, which requires drug companies to help 
underwrite the cost of FDA reviews of their products' safety and 
efficacy. This measure has enabled the FDA to eliminate backlogs and 
significantly shorten the review time of new human drug applications 
without compromising quality standards. Supported by the drug industry, 
the Prescription Drug User Fee Act illustrates the true benefits of a 
public-private partnership.
    Certainly, FDA reform did not start with this bill. The Vice 
President has been working on reforming and reinventing the FDA since 
1993. This bill codifies many of the reforms proposed by the Vice 
President's Reinventing Government Initiative. For example, it 
modernizes the regulations of biological products, eliminates the batch 
certification and monograph requirements for insulin and antibiotics, 
and streamlines the approval process for drug manufacturing changes. 
This Act also codifies reforms proposed by the FDA's Center for Devices 
and Radiological Health that will significantly improve both the rigor 
and timeliness of its premarket review of medical devices.

[[Page 1627]]

    Notably, S. 830 will expand FDA's current program to streamline the 
filing and approval of new therapies for serious or life-threatening 
conditions. It will also codify FDA regulations and practices designed 
to ensure that patients will have access to therapies for serious and 
life-threatening conditions before they are approved for marketing. The 
Act requires the Department of Health and Human Services to establish a 
databank, providing information to the public on clinical trials of 
experimental treatments for serious and life-threatening conditions.
    In addition, S. 830 includes a provision that eliminates certain 
health information dissemination restrictions, while maintaining public 
health protections. For example, product sponsors, manufacturers, or 
distributors will now be permitted to furnish to health professionals, 
providers, and others, peer-reviewed journal articles on an ``off-
label'' use of an approved or cleared drug or device, so long as the 
manufacturers commit to completing the research needed to approve such 
use and meet other specified conditions. Drug manufacturers will also be 
able to give cost data to health maintenance organizations and other 
institutional purchasers of prescription drugs, so long as it is based 
on competent and reliable scientific evidence. The Act will also resolve 
the issue of pharmacy compounding--the process of making customized 
medicines--so that legitimate pharmacy compounding is allowed, while the 
manufacture of unapproved drugs is not.
    While I am satisfied with the resolution of the issues in this 
legislation, I am also pleased that the Congress included sunsets to 
certain of the Act's provisions so that, at the appropriate time, we can 
evaluate whether the proper compromises were reached. As FDA reform did 
not start with this bill, it will not end with this bill. Even with the 
streamlining provided in S. 830, the FDA will continue to face the 
challenge of fulfilling its many responsibilities and requirements 
within available resources. The Vice President and I look forward to 
continuing our work with patient groups, industry, and the Congress to 
make sure that the FDA is meeting the challenges of the future and 
providing safe and effective products to all Americans.

                                                      William J. Clinton

The White House,

November 21, 1997.

Note: S. 830, approved November 21, was assigned Public Law No. 105-115.